Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products / 中国药房

In July 2023， the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products （hereinafter referred to as the Measures）. This article interprets the main content of the Measures， and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter， and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time， and build a national drug standard data-sharing platform based on the basic framework of user interface layer， computing processing layer， and data storage layer. Digital drug standards will be free， and access and download services for the public will be provided.

Difusão de política na prática: o caso da regulação brasileira de medicamentos / Difusión de políticas en la práctica: el caso de la regulación brasileña de medicamentos / Policy diffusion in practice: the case of Brazilian medicinal products regulation

Resumo O presente estudo busca contribuir para a melhor compreensão de processos de difusão de política com base em arenas transnacionais - mais especificamente, do processo de difusão que influenciou a regulação das Boas Práticas de Fabricação (BPF) de medicamentos no Brasil num contexto envolto por atores internacionais. Por meio de pesquisa qualitativa, analisamos o processo de adesão da Agência Nacional de Vigilância Sanitária (Anvisa) ao arranjo de cooperação Pharmaceutical Inspection Co-operation Scheme (PIC/S), iniciado em 2010 e alcançado em 2021. Foi identificado um processo influenciado por 2 constelações de difusão, motivado por interesses da agência nacional em manter sua relevância e por atores que integram o Sistema Nacional de Vigilância Sanitária, no qual o modelo de equivalência e convergência regulatória do PIC/S se mostrou fundamental para a adaptação da referência internacional em nível nacional, mantendo o sistema em funcionamento. Tal processo de difusão de política ficou mais relevante nos últimos anos por ampliar a convergência regulatória e, potencialmente, tornar mais eficiente a avaliação das BPF de medicamentos pelas diversas autoridades sanitárias.

Resumen El presente estudio pretende contribuir a una mejor comprensión de los procesos de difusión de políticas, más concretamente, del proceso de difusión que influyó en la regulación de las Buenas Prácticas de Fabricación (BPF) de medicamentos en Brasil, a partir de arenas transnacionales. A través de una investigación cualitativa, analizamos el proceso de adhesión de la Agencia Nacional de Vigilancia Sanitaria (Anvisa) al Esquema de Cooperación de Inspección Farmacéutica (PIC/S), iniciado en 2010 y alcanzado en 2021. Se identificó un proceso influenciado por dos constelaciones de difusión, motivado por el interés de la agencia nacional en mantener su relevancia y por los actores que componen el Sistema Nacional de Vigilancia Sanitaria, en el que el modelo de equivalencia y convergencia normativa del PIC/S resultó fundamental para la adaptación de la referencia internacional al ámbito nacional, manteniendo el sistema nacional en funcionamiento. Este proceso de difusión de políticas adquirió aún más relevancia en años recientes al ampliar la convergencia normativa y hacer potencialmente más eficiente la evaluación de las BPF de los medicamentos por parte de las distintas autoridades sanitarias.

Abstract The present study seeks to contribute to a better understanding of policy diffusion processes, more specifically, of the diffusion process from a transnational arena that influenced the regulation of Good Manufacturing Practices (GMP) for medicinal products in Brazil in a context surrounded by international authorities. By conducting qualitative research, we analyzed the process of adhesion of the Brazilian Health Regulatory Agency (Anvisa) to the Pharmaceutical Inspection Co-operation Scheme (PIC/S), initiated in 2010 and achieved in 2021. A process influenced by two constellations of diffusion was identified, motivated by the national agency's interests in maintaining its relevance and by actors that make up the National Sanitary Surveillance System, in which the PIC/S model of regulatory equivalence and convergence proved to be fundamental for the adaptation of the international reference to the national level, keeping the national system functioning. Such a policy diffusion process became even more relevant in the past years due to the expansion of regulatory convergence and potentially making the various health authorities' GMP assessment of medicinal products more efficient.

Analysis of simplified registration of traditional herbal medicinal products in European Union / 国际中医中药杂志

Europe occupies an important position in the world herbal medicine market. The registration of Traditional Chinese Medicine (TCM) in EU is of great significance to the internationalization of TCM. The European Medicines Agency (EMA) has designed a relatively complete management system and regulatory guidelines for the registration and supervision of herbal medicinal products. The promulgation of the DIRECTIVE 2004/24/EC (2004 / 24 / EC) indicates that TCM could enter the EU market through simplified registration. Based on the registration conditions, registration authority and document guideines of Traditional Herbal Medicinal Products (THMPs) in EU, this paper analyzes the application requirements of simple registration of traditional herbal products in EU, and provides suggestions for the simplified registration of TCM in EU according to the registration requirements of medicinal history, quality requirements and application data format.

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries / Utilización de decisiones de autoridades regulatorias de otras jurisdicciones para aprobar nuevos productos medicinales en países de América Latina y el Caribe / Uso de decisões regulatórias de outras jurisdições para aprovação de novas especialidades farmacêuticas em países da América Latina e Caribe

ABSTRACT Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries' regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators' websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

RESUMEN Objetivo. Describir el estado actual de la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones en América Latina y el Caribe mediante la evaluación de los marcos regulatorios nacionales para la aprobación de nuevos medicamentos y establecer los organismos regulatorios extranjeros que se consideran autoridades regulatorias confiables para cada país. Métodos. Se realizaron búsquedas en los sitios web de las autoridades regulatorias de América Latina y el Caribe para identificar las regulaciones oficiales para la aprobación de nuevos medicamentos. La recopilación de datos se llevó a cabo en diciembre del 2019 y se completó en junio del 2020 para los países del Caribe. Dos equipos independientes recopilaron información sobre el reconocimiento directo o los procedimientos abreviados para la aprobación de nuevos medicamentos y los autoridades regulatorias de referencia (confiables) así definidos en la legislación nacional correspondiente. Resultados. Se encontraron documentos regulatorios sobre la aprobación de nuevos productos en los sitios web de veinte organismos regulatorios de América Latina y el Caribe, que abarcaban 34 países. Siete países no aceptan la utilización de decisiones de autoridades regulatorias extranjeras. Trece autoridades regulatorias (Argentina, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, México, Panamá, Paraguay, Perú, República Dominicana, Uruguay y el sistema regulador único para quince Estados del Caribe) aceptan de manera explícita confiar las decisiones para aprobación de nuevos medicamentos emitidas por la Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá. Diez países aceptan también utilizar las autorizaciones para la comercialización de Australia, Japón y Suiza. Argentina, Brasil, Chile y México son autoridades de referencia para ocho autoridades regulatorias en la región. Conclusiones. La utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se han convertido en una práctica común en América Latina y el Caribe. Trece de veinte autoridades regulatorias reconocen directamente o abrevian el proceso de aprobación de nuevos medicamentos en caso de que hayan recibido previamente la aprobación por parte de un organismo regulatorio de otra jurisdicción. La Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá son las autoridades regulatorias de otras jurisdicciones en las cuales los reguladores de América Latina y el Caribe confían más.

RESUMO Objetivo. Descrever a prática atual de uso de decisões regulatórias de outras jurisdições na América Latina e no Caribe (ALC) mediante avaliação os marcos regulatórios dos países para aprovação de novos medicamentos e verificar, para cada país, quais entidades reguladoras estrangeiras são consideradas autoridades reguladoras de confiança por cada país. Métodos. Foi realizada uma pesquisa nos sites das autoridades reguladoras da ALC para identificar as regulamentações oficiais para aprovação de novos medicamentos. A coleta de dados foi feita em dezembro de 2019 e concluída em junho de 2020 para os países do Caribe. Dois grupos independentes coletaram informações sobre o reconhecimento direto ou o procedimento abreviado para aprovação de novos medicamentos e as autoridades reguladoras de referência (de confiança) definidas como tal pela respectiva legislação nacional. Resultados. Documentos regulatórios relacionados à aprovação de novos produtos foram obtidos de 20 sites de órgãos reguladores da ALC, abrangendo 34 países. Sete países não admitem o uso de decisões regulatórias de entidades reguladoras externas. Treze autoridades reguladoras (na Argentina, Colômbia, Costa Rica, El Salvador, Equador, Guatemala, México, Panamá, Paraguai, Peru, República Dominicana, Uruguai e o Sistema Regulador do Caribe unificado para 15 Estados caribenhos) admitem explicitamente a admissibilidade de decisões regulatórias para aprovação de novos medicamentos de outras jurisdições, quais sejam: Agência Europeia de Medicamentos (EMA), Agência Reguladora de Alimentos e Medicamentos (FDA) dos EUA e Health Canada. Dez países também aceitam decisões para autorização de comercialização da Austrália, Japão e Suíça. Argentina, Brasil, Chile e México são autoridades de referência para oito agências reguladoras. Conclusões. O uso de decisões regulatórias de outras jurisdições tornou-se prática comum na América Latina e Caribe. Treze das 20 agências reguladoras reconhecem diretamente ou abreviam o procedimento de aprovação de novos medicamentos no caso de tal aprovação já haver sido concedida por uma autoridade reguladora de outra jurisdição. A EMA, a FDA e a Health Canada são as autoridades estrangeiras nas quais as agências reguladoras da América Latina e Caribe mais confiam.

Caracterización clínica y epidemiológica de pacientes con psoriasis y prescripción de terapia biológica en Venezuela: estudio transversal / Clinical and epidemiological characterization of patients with psoriasis and the prescription of biological therapy in Venezuela: a cross-sectional study

Introducción La psoriasis es una enfermedad crónica que compromete la piel, padecida por cerca de 125 millones de personas en todo el mundo. En un grupo determinado de pacientes, también puede afectar el sistema articular. Para el control y seguimiento de los pacientes con psoriasis se estableció la aplicación de los índices de severidad del área de psoriasis y de calidad de vida dermatológica. Ambos parámetros son necesarios para el inicio de terapia biológica, según lo establecido en la guía de manejo de psoriasis (2015) del comité nacional de enfermedades reumatológicas, inmunológicas y de metabolismo óseo del Instituto Venezolano de los Seguros Sociales. Objetivo Caracterizar las variables clínicas, epidemiológicas y la prescripción de terapia biológica en los pacientes con psoriasis que acceden al programa de dispensación de alto costo de la farmacia del Instituto Venezolano de los Seguros Sociales. Método Es un estudio descriptivo, transversal. Resultados Se evaluaron 374 expedientes, donde el sexo masculino fue más frecuente con 56,1% (p < 0,001), provenientes en su mayoría de la ciudad de Caracas, en la comparación de los grupos de edad con el sexo, se observó que existía una diferencia entre estos (p < 0,05). El 57,5% usó previamente metotrexato; 6,68% biológicos; 3,2% esteroides tópicos y 31% no reportó qué tipo de terapia previa recibía. Dentro de las presentaciones clínicas, 70% correspondió a la psoriasis en placa. El 79% de los pacientes presentaba actividad moderada según el índice de la severidad del área de psoriasis, y al 11% se les realizó el índice de calidad de vida dermatológica, de los cuales 39% presentaban un efecto extremadamente importante. El rango anérgico de la prueba de Mantoux representó 70,9% de los casos, donde al 0,3% le fue realizado la prueba de Booster, y la radiografía de tórax se reportó normal en 95%. El medicamento biológico más demandado fue el etanercept con 52% de los casos. Conclusiones El sexo masculino y su relación con la psoriasis fue un hallazgo de importancia, como también se evidenció la necesidad de mejorar los componentes administrativos en la gestión de los formatos de solicitud de medicamentos y fortalecer la aplicación de la clinimetría con elemento de buena práctica médica.

Introduction Psoriasis is a chronic disease that affects the skin. One hundred twenty-five million people around the world suffer from this condition. In specific groups of patients, the joints may also be involved. To control and follow-up patients with psoriasis, psoriasis area severity and dermatological quality of life measurements were established. Both parameters are necessary for the initiation of biological therapy, as specified in the psoriasis management guide (2015) of the national committee of rheumatological, immunological, and bone metabolism diseases of the Venezuelan Institute of Social Security. Objective To characterize the clinical and epidemiological variables and the prescription of biological therapy in patients with psoriasis who access the high-cost dispensing program of the Venezuelan Institute Social Security (IVSS) pharmacy. Methods This is a descriptive, cross-sectional study. Results A total of 374 patient records were assessed. The male gender was more frequent, with 56.1% (p <0.001), mostly from Caracas city. In comparing age groups with sex, a difference among these was observed (p <0.05). 57.5% previously used methotrexate, 6.68% biological, 3.2% topical steroids, and 31% did not report which type of previous therapy they had received. Amongst the clinical presentations, 70% corresponded to plaque psoriasis. 79% of the patients presented moderate activity according to the Psoriasis Area and Severity Index (PASI): Eleven percent were assessed with the Dermatology Life Quality Index (DLQI); 39% of them reported an extremely important effect. The anergic range of the Mantoux test represented 70.9% of the cases, and 0.3% took the booster evaluation. Chest X-ray was reported normal in 95% of the cases. The most demanded biological medicine was etanercept, in 52% of the cases. Conclusions Male gender and its association with psoriasis was an important finding. The need to improve the administrative components in completing the medication request formats and strengthen clinical measurements and good medical practice was also found.

Alteraciones endocrinas asociadas al uso medicamentos en el Programa Distrital de Farmacovigilancia de Bogotá durante el periodo 2012 a 2016 / Medication-use related endocrine disruption reported to the local pharmacovigilance program in Bogota, during 2012- 2016 / Alterações endócrinas associadas ao uso de medicamentos no Programa Distrital de Vigilância farmacológica em Bogotá no período 2012-2016

Objetivos. Conocer las reacciones adversas tipo endocrino asociado al uso de medicamentos y reportado al Programa Distrital de Farmacovigilancia de Bogotá durante el periodo 2012 a 2016. Materiales y métodos. Los reportes analizados corresponden al periodo del 1º de enero de 2012 al 31 de diciembre de 2016 del Programa Distrital de Farmacovigilancia. Su análisis se hizo mediante algoritmos de causalidad y por tipo de evento. Resultados. Se analizaron 85 reportes. Uno de ellos relacionado con una sospecha de problema de calidad del medicamento, los otros 84 relaciona-dos con reacciones adversas sobre los cuales se centró la investigación. De los 84 reportes, 36 (42,9 %) corresponden a reacciones adversas a medicamento tipo A y 26 (31 %) a reportes de reacciones adversas a medicamentos de tipo fallo terapéutico. Los principales efectos secundarios a los medicamentos fueron el aumento de los niveles de hormona paratiroidea por uso de cinacalcet en 27 (34,1 %) reportes, seguidas por el síndrome de Cushing relacionado con la administración de prednisolona en 12 (14,1 %), bocio por uso de adalimumab en 12 (14,1 %), hiperprolactinemia por el uso de risperidona en 10 (11,8 %) e hipotiroidismo inducido por amiodarona en 3 (3,4 %). Conclusiones. El desarrollo de estos estudios permite conocer las principales reacciones adversas que se presentan durante el uso habitual de los medicamentos, así como su perfil de seguridad.

Objective. Becoming familiar with medication-use related endocrine disruption reported to the local pharmacovigilance program in Bogotá during 2012-2016.Tools and methods. Analyzed reports are dated between January 1st, 2012 and December 31st, 2016 and were gathered from the Pharmacovigilance Program in Bogotá. The analysis of the said reports was conducted through causality algorithms and event type.Results. Out of 87 analyzed reports, two were not included in the study due to lack of information for its classification in one case and, medication-related problems in another case. 36 reports (42.9 %) were found to have adverse reaction to type A medications, while 26 reports (34.1%) were found to have medication related problem type therapeutic failure. The main medication related problems were associated to the use of Cinacalcet with increased levels of parathormone in 27 out of 87 analyzed reports in this study. Other medication related problems found were: Cushing Syndrome, associated with the use of prednisolone in 12 reports; Goiter associated to the use of adalimumab in 12 reports; Hyperprolactinemia associated to the use of Risperidone in 10 reports and, Hypothyroidism associated to the use of Amiodarone in 3 reports. Conclusions: Carrying out such studies allows for the understanding of the main medication-use problems that are shown during common use of medications, as well as their safety profile.

Objetivo. O objetivo do artigo é conhecer as alterações endócrinas associadas ao uso de medicamentos reportadas pelo Programa Distrital de Vigilância farmacológica em Bogotá. Materiais e métodos. Os reportes analisados correspondem ao período de janeiro de 2012 a dezembro 2016 e a analise foi realizada com algoritmos de causalidade e por tipo de evento. Resultados. Foram analisados 87 reportes, embora no final dois deles foram desconsiderados, um por corresponder a um problema relacionado com o medicamento e o outro por falta de informações para classifica-lo. Encontraram-se 36 (42%) de reportes associados a reações adversas perante os medicamentos tipo A e 26 (31%) de reportes de RAM tipo falho terapêutico. As principais RAM foram por uso de cinacalcet com aumento dos níveis de parathormona em 27 reportes (34%), seguidas de Síndrome de Cushing relacionado com prednisolona em 12 reportes (14,1%), bócio por uso de adalimumab em outros 12 re-portes, hiperprolactinemia por uso de risperidona em 10 casos (11,8%) e hipotiroidismo induzido por amiodarona em 3 casos. Conclusoes. O desenvolvimento destes estudos, permite conhecer as principais reações adversas causadas pelo uso habitual dos medicamentos mesmo como seu perfil de segurança.

Medicamentos homeopáticos en el tratamiento del climaterio y la menopausia: una revisión / Homeopathic medicinal products in the treatment of climateric and menopause: a review

RESUMEN Durante el climaterio y la menopausia debido a cambios hormonales pueden presentarse en las mujeres síntomas que afectan la calidad de vida y las relaciones interpersonales. La homeopatía puede ser utilizada como terapia alternativa o complementaria en el manejo de sus síntomas proporcionando múltiples beneficios, escasos efectos secundarios, ahorro de recursos y apertura de una nueva línea para investigar. La bibliografía sobre este tema es insuficiente y se encuentra dispersa lo que dificulta la consulta por parte de los profesionales que la necesitan. Se realizó una revisión bibliográfica con el objetivo de identificar y describir los principales medicamentos homeopáticos que pueden ser utilizados para tratar los síntomas durante el climaterio y la menopausia. Los artículos se identificaron básicamente a través de la búsqueda automatizada en las bases de datos Scielo, PubMed y EBSCO, entre los meses de enero de 2017 a mayo de 2018. Se revisaron aquellos libros y artículos que por su trascendencia fueron considerados como referentes en el tema. Se escogieron 26 referencias bibliográficas que se ajustaban a los objetivos de esta investigación. Fueron identificados y descritos 22 medicamentos homeopáticos susceptibles de ser utilizados en el tratamiento de los síntomas de climaterio y menopausia por lo que puede ser una fuente útil de consulta (AU).

ABSTRACT During the climacteric and menopause, due to hormonal changes, women may present symptoms affecting life quality and interpersonal relations. Homeopathy could be used as an alternative or complementary therapy in the management of those symptoms, providing several benefits, scarce secondary effects, saving resources and opening a new research field. There is not enough bibliography on this topic and it is dispersed, making it difficult for the professional to consult it when it is necessary. A bibliographic review was carried out with the objective of identifying and describing the main homeopathic medicinal products that could be used to treat the symptoms during the climacteric and menopause. The articles were identified mainly through an automated search in Scielo, PubMed and EBSCO databases, in the period from January 2017 and May 2018. Those books and articles considered as referents in the topic because of their transcendence were reviewed. 26 bibliographic references were chosen because they complied with the objective of this research. 20 homeopathic medicinal products capable of being used in the treatment of the climacteric and menopause symptoms were identified and described, being therefore a useful consultation source (AU).

Biomonitoring for traditional herbal medicinal products using DNA metabarcoding and single molecule, real-time sequencing

Global concerns have been paid to the potential hazard of traditional herbal medicinal products (THMPs). Substandard and counterfeit THMPs, including traditional Chinese patent medicine, health foods, dietary supplements, etc. are potential threats to public health. Recent marketplace studies using DNA barcoding have determined that the current quality control methods are not sufficient for ensuring the presence of authentic herbal ingredients and detection of contaminants/adulterants. An efficient biomonitoring method for THMPs is of great needed. Herein, metabarcoding and single-molecule, real-time (SMRT) sequencing were used to detect the multiple ingredients in Jiuwei Qianghuo Wan (JWQHW), a classical herbal prescription widely used in China for the last 800 years. Reference experimental mixtures and commercial JWQHW products from the marketplace were used to confirm the method. Successful SMRT sequencing results recovered 5416 and 4342 circular-consensus sequencing (CCS) reads belonging to the ITS2 and regions. The results suggest that with the combination of metabarcoding and SMRT sequencing, it is repeatable, reliable, and sensitive enough to detect species in the THMPs, and the error in SMRT sequencing did not affect the ability to identify multiple prescribed species and several adulterants/contaminants. It has the potential for becoming a valuable tool for the biomonitoring of multi-ingredient THMPs.

The Current Global Status and Production Trends of Plasma Fractionation / 대한수혈학회지

The demand for medicinal products derived from plasmas are increasing on a global scale. In particular, the demand for intravenous immunoglobulin has continuously been increasing. The increase in the capacity of commercial plasma fractionators is prominent compared with that of non-profit plasma fractionators; thus, the percentage of plasmapheresis has increased with respect to that of plasma from whole blood. The inequality between the consumption of plasma-derived medicinal products and supply of raw plasma among developed countries and developing countries is due to the direct, proportional relationship between the consumption of plasma-derived medicinal products and the size of gross domestic products. Each country decides on its own system to achieve a stable supply of plasma-derived medicinal products. Although domestic production is an ideal option, many countries establish contracts with plasma fractionators. Owing to a great ripple effect, safety measures are increasingly applied, so detailed review should be conducted with consideration given to the cost-effectiveness and the situation unique to each country.

Research and practice on readability test of Danshen Capsule for registration as THMPs in EU / 中草药

The package leaflet is a legal document relevant with drug information, which plays an important role for instructing the rational use of the medicinal product for the patient population. During the registration application in the EU countries, the patient readability test on package leaflet is the essential requirement to ensure the leaflet information easy-to-understand and avoid any risk caused by misunderstanding. The readability research on package leaflet can improve its quality and drug use safety to patients. Currently, CFDA does not publish any regulation/guidance on the drug application in China. By the successful case of registration application of Danshen Capsule as the herbal medicine in the EU, this paper not only discusses the relevant requirements of readability test in the EU, but also offers the regulatory advice on future regulations of readability research of the pharmaceutical products in China.

Analysis on value of Community Herbal Monograph in registration of traditional Chinese medicinal products in Europe / 中草药

The Community Herbal Monograph (CHM) is an official document which reflects the scientific opinion of European Medicines Agency (EMA) and plays an important role in technical harmonization of the herbal medicinal products. The role of CHM is very similar with the centralized procedure in the EU level as it represents the technical coordination results of the assessment about safety and efficacy of herbal medicine. The monograph and national procedure, decentralized procedure, and mutual recognition procedure together constitute the coexistence characteristic of centralization and decentralization of the EU medical legislation. The CHM and the traditional herbal medicine registration also constitute the core content of Directive 2004/24/EC in the EU and member state level respectively. And the CHM plays an important role in the registration of traditional herbal medicinal products in the EU member state. However, it has not yet been fully studied by domestic experts and scholars. This paper makes intensive studies on the value of CHM and analyzes the application of monograph in traditional herbal medicine registration. The purpose is to clarify the value and importance of CHM in the registration of traditional Chinese medicine in EU and to provide reference for the Chinese enterprises which are aspiring to open up the EU market.

Propuesta de implementación de sistema de vigilancia sanitaria de medicamentos de uso veterimario en etapa postcomercialización / Proposed implementation of health surveillance system for veterinary use drugs on stage postmarketing

El presente trabajo de grado tiene como objetivo general: Proponer la implementación del sistema de vigilancia sanitaria de medicamentos de uso veterinario en etapa postcomercialización en los expendios agropecuarios de los mercados principales del Municipio Bolivariano Libertador, Distrito Capital. Metodológicamente, la investigación se ubicó dentro del paradigma cuantitativo y cualitativo, bajo la modalidad de proyecto factible, de tipo descriptiva y con un diseño de campo. La elección de la muestra respondió al criterio de la investigadora, estuvo representada por el total de la población de los expendios agropecuarios que comercializan en los mercados principales del Municipio Bolivariano Libertador, Distrito Capital. La recolección de datos se realizó a través de la técnica de la entrevista y como instrumento el cuestionario estructurado y una guía de observación durante el segundo trimestre Mayo-Junio 2013. Luego de la aplicación de los procedimientos de análisis a través de la matriz DOFA, se concluye que: los alcances de la acción reguladora del sistema de vigilancia, no responde de manera eficiente al fortalecimiento de los vínculos interinstitucionales para la vigilancia, prevención y control en los expendios agropecuarios. Posterior a ello, se hizo necesaria la elaboración de una propuesta para la implementación del sistema de vigilancia sanitaria de medicamentos de uso veterinario mediante la creación de dos coordinaciones dentro de la dirección de Salud Animal del ente regulador y el diseño de instrumentos de inspección enmarcados dentro de la Ley para dar cumplimiento al objetivo general de la propuesta: Proponer un sistema de vigilancia sanitaria para medicamentos de uso veterinario en la etapa post-comercialización en los expendios agropecuarios de los mercados principales del Municipio Bolivariano Libertador del Distrito Capital..

The present degree work has as general aim: To propose the implementation of the sanitary surveillance system of medicines for veterinary use in the post-marketing stage in the agricultural expenditures of the principal markets of the Bolivarian Municipality of Libertador, Capital District. Methodologically, the investigation was located inside the quantitative and qualitative paradigm, under the modality of feasible project of descriptive type with a field design. The election of the sample answered to the criterion of the investigator, it was represented by the whole population of the agricultural expenditures that commercialize inside the principal markets of the Bolivarian Municipality of Libertador, Capital District. The compilation of the information was performed applying the interview and as a resource the constructed questionnaire and observation guide during the second trimester of the year, May - June, 2013. After the application of the analysis procedures by the SWOT analysis, there concludes that: the goals of the regulatory action of the surveillance system, does not answer in a very efficient way to the strengthening of the interinstitutional links for the surveillance, prevention and control inside the agricultural expenditures. Later, it was necessary the elaboration of a proposal for the implementation of the sanitary surveillance system of medicines for veterinary use by means of the creation of two coordinations Inside the Animal Health Direction of the regulatory entity and the design of inspection instruments framed inside the Law, in order to fulfill the general aim of the proposal: To propose a sanitary surveillance system of medicines for veterinary use in the post-marketing stage inside the agricultural expenditures of the principal markets of the Bolivarian Municipality of Libertador, Capital District.

Herbal Reference Standards: applications, definitions and regulatory requirements

This review concerns the definitions and appropriate analytical characterisations of herbal reference standards within the framework of regulatory requirements. It describes currently applicable rules and regulations, as well as future issues relating to the European Pharmacopoeia and United States Pharmacopoeia. It provides an update on the use and availability of pharmacopoeial (EP and USP) herbal reference standards since our last review was published in 2009. The continuing challenges facing manufacturers, suppliers and analysts are discussed on the basis of exemplary reference substances for herbal products in medicinal and food products. The article also reviews the special aspects of Brazilian stipulations (Brazilian Pharmacopoeia, Anvisa) by comparison with European regulations. The term herbal products as used throughout this article refers to herbal drugs, herbal preparations and finished herbal medicinal products unless a different meaning is obvious from the context. More specific terms are used where necessary.

Legislation an essential tool for ensuring access to medicines policy goals.

Effective national legislation is critical to support the activities of a Medicines Regulatory Authority. However, the law is an under-recognized mechanism for managing issues in the implementation of access to medicines and other medicines policy goals. Regulations are a more flexible tool, have legal effect and the advantage that they can be created or changed without the need to go to the Parliament. Closer collaboration between the health and legal sectors is important as is political commitment for enforcement of the law. Some regional case studies illustrate the opportunities to use the law as an effective tool to implement medicine policies and to meet access to medicine challenges.

The suggestions on the entry of Chinese medicines into European Community monographs for traditional herbal medicinal products / 国际中医中药杂志

Directive 2004/24/EC of the European Parliament and the Council entered into force on April 30th, 2004. After 7 years, there is no Chinese medicine to be registered successfully in European market as traditional herbal medicinal products. The thesis gives some ideas to tackle this problem. Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products (EMEA/HMPC/182320/2005) published by European Medicines Agency is an important guidance for traditional herbal products to enter European Community monographs. The thesis introduces and details the procedure as well as gives feasible suggestions about the procedure. It suggests that Chinese medicines enter European Community monographs first, and then apply the registration according to the directive 2004/24/EC. This is an easier access to European market.

Ensuring Compliance of Raw Herbal Materials Stemmed from China with European Good Agricultural and Collection Practice / 中草药·英文版

Asimplified European procedure now allows the registration of traditional herbal medicines as medicinal products even without the support of clinical data.This procedure entails the requirement that those products comply with European Good Manufacturing Practice for medicinal products,which in turn implies that the raw herbal materials comply with the European Guidelines for Good Agricultural and Collection Practice.On the basis of a comparison between European Good Agricultural and Collection Practice and China Good Agricultural Practice,as well as direct observation made at sites in China,we issue some recommendations to facilitate good communication between the Chinese producer and European pharmaceutical customer,with a view to ensure full compliance with European expectations.

Implication of UK Defective Medicinal Products Guide for China / 中国药房

OBJECTIVE:To provide reference for the improvement on the management of defective medicinal products in China.METHODS:The current UK Defective Medicinal Products Guide and drug recall cases were analyzed and its implication on China was discussed.RESULTS & CONCLUSIONS:The mature defective medicinal products management experiences in UK serve as a mirror for drug safety work in China.At present,the drug safety work can be intensified through clarifying the definition of defective drugs,establishing effective information exchange channel for the defective drugs,establishing evaluation system about records of drug complaints,formulating scientific operational strategies for the recall of defective medicinal products and establishing matched information distribution channel.

Avaliação da qualidade de amostras comerciais de boldo (Peumus boldus Molina), pata-de-vaca (Bauhinia spp.) e ginco (Ginkgo biloba L.) / Control quality evaluation of commercial samples of boldo (Peumus boldus Molina), pata-de-vaca (Bauhinia spp.) and ginkgo (Ginkgo biloba L.)

O presente trabalho procurou avaliar a qualidade de produtos comercializados à base de boldo, pata-de-vaca e ginco, através dos parâmetros contidos na Farmacopéia Brasileira e na literatura específica. Foram analisadas oito amostras de boldo, nove de pata-de-vaca e sete de ginco, adquiridas em farmácias na cidade do Recife. A metodologia consistiu em avaliar: os rótulos e bulas dos produtos verificando se estavam de acordo com a RDC n o 17 de 24/02/2000 e a portaria 110/97 da ANVISA; realizar análise sensorial; verificar a autenticidade das amostras e sua pureza. Todas as embalagens de boldo, pata-de-vaca e seis de ginco continham erros ou ausência de informações científicas, além da falta de bula. Na verificação de impurezas, todas as de boldo, cinco de pata-de-vaca, e uma amostra de ginco foram reprovadas. Todos os produtos analisados apresentaram alguma irregularidade segundo os códigos oficiais, sendo necessário uma maior intensificação na vigilância de produtos à base de plantas medicinais no Brasil.

This study aimed to evaluate the quality of commercial products prepared with boldo (Peumus boldus Molina), pata-de-vaca (Bauhinia spp.) and ginkgo (Ginkgo biloba L.) by using parameters from the Brazilian Pharmacopoeia and specific literature. Eight samples of "boldo", nine of "pata-de-vaca", and seven of ginkgo were analyzed, all bought from pharmacies in Recife (Pernambuco, Brazil). The methodology consisted in evaluating the products’ labels and instructions to verify their accordance to RDC n o 17 of 02/24/2000 and ANVISA (National Sanitary Surveillance Agency) decree 110/97, undertaking a sensorial analysis, and verifying the authenticity and purity of the samples. All of the packages of "boldo" and "pata-de-vaca" and six of the packages of ginkgo contained mistakes or lacked scientific information; instructions were also missing. After analyzing for impurities, all samples of "boldo", five of "pata-de-vaca", and one of ginkgo were rejected. All of the products analyzed had some sort of irregularity in relation to the official codes, making it necessary to intensify the inspection of medicinal plant products in Brazil.